Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx Squamous Cell Carcinoma

Overseen by Renata Ferrarotto, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

To learn if SAR444245 given in combination with cemiplimab can help to kill cancer cells in patients with HPV-related oropharynx cancer who are scheduled to have surgery to remove the disease

Research Team

Renata Ferrarotto, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Inclusion Criteria

The head and neck surgeon believes that you are suitable for TORS (Transoral Robotic Surgery).

Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent and in this protocol

Age ≥ 18 years old

Exclusion Criteria

History of previous malignancy other than malignancy treated with curative intent and with no evidence of active disease ≥3 years before the first dose of the study drugs and of low potential risk for recurrence. Patients with the following diagnoses represents an exception and may enroll: Non-melanoma skin cancers with no current evidence of disease, Melanoma in situ with no current evidence of disease, Localized cancer of the prostate with prostate-specific antigen of <1 ng/mL, Treated or localized well-differentiated thyroid cancer, Treated cervical carcinoma in situ, Treated ductal/lobular carcinoma in situ of the breast

Participants under anti-hypertensive treatment who cannot temporarily (for at least 36 hours) withhold antihypertensive medications prior to each IMP dosing.

Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤14 days prior to administration of investigational product. Patients with known hepatitis B, hepatitis C (HCV), or HIV infection could go on study provided the viral load is undetectable at Screening.

Treatment Details

Interventions

• Cemiplimab (Monoclonal Antibodies)
• SAR444245 (Other)

Participant Groups

Group I: SAR444245 plus Cemiplimab Experimental Treatment 2 Interventions

Participants will receive SAR444245 and Cemiplimab by vein on Day 1 of Cycles 1 and 2. Each drug's infusion should take about 30 minutes.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Sanofi

Industry Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University